Dexamethasone Intraocular Injection Recalled for Glass Particle Contamination
Imprimis is recalling intraocular injection products due to glass-like particles found in specific lots. The contamination poses a risk to eye health for patients receiving these injections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported hospitalizations or injuries. The hazard—glass contamination of an intraocular injection—poses a clear, direct risk of harm to eye tissue, but remains theoretical with no reported cases. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Imprimis NJOF, LLC is recalling certain lots of Dexamethasone-Moxifloxacin-Ketorolac Single-Use Intraocular Injection (NDC 71384-513-01) due to the presence of glass-like particles in the product.
The affected lots are 25APR001A and 25APR001B, which expire on April 3, 2026. A total of 596 boxes containing 11,920 pre-filled syringes per box were distributed nationwide.
The presence of particulate matter—specifically glass-like particles—in intraocular injections poses a risk of eye tissue damage, inflammation, or other serious complications for patients receiving these injections.
Patients who have received an injection from one of the affected lots should contact their healthcare provider immediately. Healthcare providers should cease use of products from the recalled lots and investigate whether any patient injuries or complications have occurred.
The recalled product
- Product
- Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
- Manufacturer
- Imprimis NJOF, LLC
- Category
- Drug — Ophthalmic Injection
- Hazard
- glass-contamination
- particulate-matter
- eye-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot: 25APR001A
- 25APR001B
- Expires: 04/03/2026.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27